Enterprise CRO & CDMO Contract Testing

OEM Affordable Test Manufacturer & Supplier

Global contract analytical method establishment, active ingredient screening, preclinical in vitro & animal studies, and full-spectrum clinical trials executed with industry-leading capital efficiency and uncompromised regulatory fidelity.

ICH Q2(R1) & GLP-Compliant Lab Benchmarks
300+ Scientific Personnel & Pilot Facilities
Confidential NDA & Strict IP Firewall Protection
Featured OEM Test & R&D Portfolios

Standardized & Custom Affordable Testing Solutions

Cost-effective testing does not denote compromise. Through automation, direct raw material origin pipelines, and high-throughput analytical assays, we deliver validated data packages that satisfy global pharmacopeias at fraction of Western CRO costs.

OEM Testing Service OEM In Vitro Test Research Service

OEM In Vitro Test / Research Service

Cellular viability, anti-inflammatory cytokine expression, glucose uptake, and enzymatic inhibition assays providing rapid, cost-effective efficacy screening.

Fast TAT: 10-14 Days High-Throughput
Configure In Vitro Assays
ODM Origin Study ODM Study and evaluation of botanical potency

Botanical Potency & Origin Evaluation

Quantifying secondary metabolite variance across geographical origins and seasonal harvest windows to lock in the highest active yields at optimal acquisition cost.

Dao Di Botanical Geo-Mapping
Explore Origin Screening
OEM Preclinical OEM Animal study supplier

OEM Animal Study & In Vivo Toxicology

Preclinical rodents and disease-induced animal models evaluating pharmacodynamics, metabolic pathways, and targeted organ toxicity with complete histological verification.

GLP-Adherent Study Protocols
Commission Animal Study
QC Standardization China Establishment of analysis methods

Analytical Method Establishment

HPLC, HPTLC, and GC chromatographic fingerprinting method development and validation per ICH Q2(R1) to definitively verify active purity and prevent adulteration.

LOD/LOQ Validation Included
Validate Test Method
Clinical CRO ODM Clinic study Phase 1 to Phase 4

ODM Clinical Studies (Phase I – IV)

Complete human clinical research services including IRB/ethics filings, GCP protocol design, small-cohort nutraceutical trials, and Phase I–IV pharmaceutical registration data.

GCP-Compliant Execution
Design Clinical Protocol
HTS Screening China Screening of active ingredients of plants

Phytochemical Screening & Isolation

High-throughput screening across alkaloid, flavonoid, polysaccharide, and saponin fractions to identify lead pharmacophores with target receptor affinities.

10,000+ Botanical Database
Screen Active Candidates
Toxicology Suite Toxicity studies LD50 Acute and Genotoxicity

Toxicity Studies (LD50 & Genotoxicity)

End-to-end toxicological safety packages: Ames bacterial reverse mutation, chromosomal aberration, micronucleus test, and acute oral LD50 determination.

OECD Guideline Adherent
Request Toxicity Package
CDMO Scaling Natural Herbal formulation research service

Natural Formulation & Dosage R&D

Overcoming bioavailability bottlenecks, bad taste profiles, and active degradation to produce scalable capsules, softgels, granules, oral liquids, and functional tablets.

Pilot to Batch Scale-Up
Optimize Formulation
Industry Macroeconomic White Paper

The Paradigm Shift in Affordable Analytical & Preclinical Testing

Escalating regulatory scrutiny by the FDA, EMA, and NMPA has traditionally driven contract testing budgets into unsustainable territory. Today, global pharmaceutical enterprises and nutraceutical innovators are re-engineering their procurement models around specialized OEM test manufacturers who deliver verified, pharmacopeial-grade data without Western CRO price premiums.

The Testing Cost Trilemma

Traditional testing procurement forces enterprise buyers into an uneasy compromise between capital velocity, turnaround timeline, and analytical rigor. High overhead costs at legacy contract laboratories in North America and Western Europe have created barriers for mid-cap pharma and functional food brands seeking extensive biomarker profiling and phytochemical validation.

  • 40% to 65% reduction in analytical run expenditures
  • Accelerated go-no-go screening during early-phase R&D
  • Elimination of multi-tier vendor markup fragmentation

Automation & High-Throughput Assays

Affordable testing is fundamentally engineered through modern laboratory automation. By integrating robotic liquid handling systems, ultra-high-performance liquid chromatography coupled with time-of-flight mass spectrometry (UHPLC-Q-TOF-MS), and automated HPTLC densitometry, per-sample processing time is compressed by over 70%, yielding superior reproducibility.

  • 21 CFR Part 11 compliant audit trails and digital data logs
  • Micro-volume assays minimizing precious reference standard waste
  • Simultaneous multi-analyte quantification per single injection

Evidence-Based Botanical Modernization

Global consumers and regulatory agencies now reject ambiguous botanical claims. The transition from empirical traditional herbal medicine to quantified, standardized botanical pharmaceuticals necessitates chromatographic fingerprinting, targeted receptor binding affinity assays, and full animal toxicology data before any market rollout or new drug application (NDA).

  • Batch-to-batch chemical fingerprint similarity indexes (>0.95)
  • Direct correlation between marker content and in vitro potency
  • Modernization protocols applied across 83 classic TCM formulas
China Factory 4.0 & Testing Infrastructure

Supply Chain Resilience & High-Density Laboratory Efficiency

Headquartered in the biological hub of Changsha, Hunan, MedGence leverages integrated industrial clusters, direct access to authentic Dao Di botanical cultivation bases, and centralized laboratory ecosystems to furnish global buyers with unmatched testing turnaround speed and operational resilience.

Verticalized CRO-to-CDMO Continuity

Unlike disjointed third-party testing testing brokers who outsource analytical workloads across disconnected labs, our scientific leadership operates under one unified roof. Analytical method development seamlessly transfers into our pilot plant and collaborative GMP manufacturing suites, preventing the critical data loss, delays, and friction inherent in split-vendor supply chains.

Massive Economy of Analytical Scale

Having validated standard testing procedures for nearly 400 single-herb medicines and analyzed hundreds of thousands of research batches, MedGence possesses an extensive internal reference library. This immense historical database slashes exploratory assay development timelines from months to days, drastically lowering total project development expenditures.

Strict Intellectual Property Firewalls

Operating under strict bilateral Non-Disclosure Agreements (NDAs), our entrusted research framework treats client formulas, chromatographic elution gradients, and manufacturing process parameters with military-grade secrecy. Proprietary know-how remains exclusively assigned to the client, assuring uncompromised competitive advantages across global markets.

End-to-End Scientific Capabilities

12 Integrated Natural Medicine R&D and Testing Capabilities

From early-stage botanical active discovery and analytical standardization to preclinical toxicological evaluation, GCP clinical studies, and cGMP commercial contract manufacturing.

01 · Discovery Screening of botanical active ingredients in plants

Botanical Active Ingredient Screening

Plants contain alkaloids, polysaccharides, saponins and many other bioactive compounds. Using our accumulated phytochemical data and analytical capacity, we identify which substances best deliver your target effect — and which plant sources contain them at the highest density — balancing cost efficiency with environmental sustainability.

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02 · Sourcing Science Potency evaluation of botanical actives by origin and harvest season

Potency Evaluation by Origin & Season

The same species can vary widely in active-ingredient potency depending on growing region, harvest season and the plant part used. We quantify these differences so you can lock in the optimal origin, harvest window and plant part, building a high-yield, cost-effective sourcing strategy.

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03 · Analytics HPLC and HPTLC analytical method establishment

Analytical Method Establishment

A validated test method is the foundation of quality control and market trust. We develop identification and assay methods using HPTLC, HPLC, GC and chromatographic fingerprinting, giving your QC team reliable tools to confirm identity, content and batch-to-batch consistency.

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04 · Process Manufacturing process study for active ingredients

Process Study for Active Ingredients

Once a target ingredient is confirmed, production economics decide competitiveness. We optimize raw-material pretreatment, extraction, purification and drying — the critical parameters that determine yield, purity and scale-up success — while reducing pressure on natural resources.

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05 · Formulation Manufacturing process study for finished natural products

Process Study for Finished Products

Turning actives into consumer products can cause content loss, poor solubility or unpleasant taste. Our process scientists resolve these formulation challenges so the finished product retains its active content and delivers the expected user experience.

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06 · Safety Toxicity studies LD50 Acute Chronic Genotoxicity

Toxicity Studies (LD50, Acute & Chronic)

Safety must be proven before a product reaches the market. We perform acute toxicity (LD50), chronic toxicity and genetic toxicity studies, giving you the evidence to launch effective, safe products with confidence.

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07 · In Vitro In vitro test of natural active ingredients

In Vitro Testing & Cell Assays

Cell- and organ-level assays reveal how tissues respond to an active ingredient at a fraction of the time and cost of in vivo work. In vitro data is especially valuable for go/no-go decisions in programs such as blood-glucose management or antiviral development.

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08 · Preclinical Animal study for efficacy and safety

Animal Studies & Disease Models

Toxicity and efficacy studies in animal models provide fast, affordable evidence that a product is effective and harmless — a particularly meaningful reference for dietary supplements and cosmetics before human testing.

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09 · Clinical Clinical study Phase 1 to Phase 4

Clinical Studies (Phase I–IV)

For new actives or formulas developed under contract research, we arrange small-group human trials for dietary supplements as well as Phase I, II, III and IV clinical studies required for a new drug application (NDA).

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10 · TCM Science Natural herbal formulation research service

Natural Formulation Research

Drawing on deep TCM research experience, we design natural formulations that enhance supplement efficacy or form the basis of new medicines — covering formula design, raw-material standards, analytical methods, process improvement, efficacy and toxicity studies, as a full package or as individual tasks.

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11 · OEM Supply Contract manufacturing OEM for botanical active ingredients

OEM Supply of Active Ingredients

Our own pilot plant and partner factories, directly managed by our technical team, transfer study results smoothly into production. Actives are supplied as concentrated liquids, powders, pastes or volatile oils — with your product information kept strictly confidential.

Request specifications
12 · Finished Form CDMO contract manufacturing for finished herbal products

OEM/CDMO Finished Dosage Manufacturing

Full contract development and manufacturing for oral liquids, capsules, softgels, tablets, soluble powders and granules — backed by our technical expertise to guarantee timely delivery, reliable quality and non-disclosure of your know-how.

Request specifications
Structured Methodological Execution

From Botanical Raw Herb to Registered Product: The 6-Stage Gateway

Engage MedGence for an isolated analytical protocol or commission the entire translational lifecycle. Each phase terminates in an audited, regulatory-grade milestone deliverable.

01

Screen & Source

Identify the most effective bioactive compounds and determine the optimal botanical geographic origin, harvest season, and plant anatomical part displaying the highest marker density.

Deliverable: Target & Sourcing Feasibility Report
02

Standardize & Analyze

Develop and validate high-precision HPTLC, HPLC, GC, and chromatographic fingerprinting methodologies alongside definitive raw-material release quality specifications.

Deliverable: Validated Methods & Monograph Specs
03

Optimize the Process

Establish exact parameters for botanical pretreatment, dynamic solvent extraction, column chromatographic purification, vacuum concentration, and spray-drying scale-up.

Deliverable: Critical Process Parameters (CPP) Dossier
04

Prove Safety & Efficacy

Execute in vitro target receptor binding assays, cellular metabolic models, and in vivo animal studies including acute oral LD50, chronic toxicology, and GLP genotoxicity screens.

Deliverable: Audited Preclinical Data Package
05

Clinical Validation

Coordinate randomized, double-blind, placebo-controlled human trials for dietary claims or complete GCP Phase I–IV clinical investigations required for formal NDA registration.

Deliverable: Biostatistical Clinical Study Report (CSR)
06

Manufacture & Supply

Execute validated pilot-scale to commercial-scale cGMP production of standardized concentrated active extracts or finished dosage forms with batch-to-batch consistency guarantees.

Deliverable: Certificate of Analysis & Commercial Supply
Audited R&D Capacity & Metrics

Proven Scale in Natural Medicine & Testing Research

Over 14+ years of specialized execution, serving national pharmaceutical conglomerates, Class-3A university medical centers, and international brand owners.

14+
Years of Specialized R&D

Continuous contract research operations

300+
Scientific Personnel

Ph.D. & Master level chemists & toxicologists

100+
Pharma Clients & Hospitals

Leading domestic & multinational enterprises

100+
Innovative Projects Developed

Novel molecules, formulations & assays

83
Classic TCM Formulas Modernized

Evidence-backed analytical monographs

22
Novel Natural Medicines

Advanced botanical drug candidates

56
Hospital Preparation Approvals

Registered hospital medical formulations

~400
Single-Herb Standards Established

Quality benchmarks & active profiles

Global Enterprise Use-Cases

Targeted Application Scenarios Across Regulated Global Markets

How overseas brand innovators, pharmaceutical developers, and procurement heads configure our OEM testing services to accelerate compliance and de-risk commercialization.

European Botanical Adulteration Prevention

Scenario: A premier European herbal extract importer faced intermittent supply adulteration and batch inconsistency across imported Ginkgo biloba and Panax ginseng raw lots.

MedGence Execution: Established an automated HPTLC and HPLC fingerprinting assay framework adhering to European Pharmacopoeia (EP) guidelines. By quantifying ratio relationships among hallmark flavonoid glycosides and terpene lactones, adulterants were rapidly detected at a per-test cost 60% below EU domestic contract labs.

US Dietary Supplement Structure/Function Substantiation

Scenario: A US direct-to-consumer nutraceutical leader required rigorous in vitro and animal pharmacological evidence to support cognitive enhancement structure/function claims without triggering FDA warning letters.

MedGence Execution: Delivered a two-tier preclinical package: in vitro acetylcholinesterase (AChE) enzyme inhibition kinetics paired with rodent Morris water maze cognitive performance testing, supplying fully substantiated data files within an 8-week delivery cycle.

Cosmeceutical Safety & Skin Barrier Validation

Scenario: An Asian-Pacific skincare company developing a patented soothing serum derived from Centella asiatica needed to replace legacy animal tests with alternative OECD-compliant safety and efficacy assays.

MedGence Execution: Implemented in vitro reconstructed human epidermis (RhE) irritation assays (OECD TG 439) combined with trans-epidermal water loss (TEWL) inhibition evaluations, providing definitive non-animal cosmetic testing documentation acceptable to international authorities.

Strategic Ecosystem

Trusted by Leading Pharmaceutical Groups & University TCM Hospitals

Our contract testing and R&D pipelines power major public pharmaceutical corporations, research universities, and hospital preparation centers across Asia and overseas markets.

Beijing Tongrentang Group China Beijing Tongrentang
China Resources Sanjiu CR Sanjiu Pharmaceutical
Sunflower Pharmaceutical Sunflower Pharmaceutical
Livzon Pharmaceutical Group Livzon Pharmaceutical Group
Dihon Pharmaceutical Dihon Pharmaceutical
Golden Throat Group Golden Throat Holdings
Yangtzi River Pharmaceutical Yangtzi River Pharma
Beihai Gofar Chuanshan Biological Beihai Gofar Biological
Humanwell Healthcare Humanwell Healthcare
SCIMYTH Pharmaceutical SCIMYTH Pharmaceutical
Shandong Hanfang Shandong Hanfang Pharma
Luoxin Pharmaceutical Luoxin Pharmaceutical
Guangdong Zhongsheng Guangdong Zhongsheng
Hunan Brilliance & Abundance Brilliance & Abundance
Apeloa Pharmaceutical Apeloa Pharmaceutical
Hunan Heng Chang Pharmaceutical Hunan Heng Chang Pharma
Baotou TCM Baotou TCM Pharma
Kamp Medicine Kamp Medicine
Guangxi Santo Pharmaceutical Guangxi Santo Pharma
Hunan Kangshou Pharmaceutical Hunan Kangshou Pharma
Jiangxi Juwang Pharmaceutical Jiangxi Juwang Industry
Beijing Tcmages Beijing Tcmages Pharma
Guizhou Ruihe Pharmaceutical Guizhou Ruihe Pharma
Anhui CR Jinchan Anhui CR Jinchan
Kangmei Pharmaceutical Kangmei Pharmaceutical
Hunan Tianjicaotang Hunan Tianjicaotang
Jiangxi Kingstone Unite Jiangxi Kingstone Unite
Shuguang Hospital Affiliated to Shanghai University of TCM Shuguang Hospital, Shanghai TCM
Hunan Province Directly Affiliated TCM Hospital Hunan Direct TCM Hospital
First Hospital of Hunan University of CM 1st Hosp. Hunan Univ. of CM
Second Xiangya Hospital Central South University 2nd Xiangya Hosp. CSU
Second Hospital of Hunan University of CM 2nd Hosp. Hunan Univ. of CM
Orthopedics of TCM Zhuzhou City Zhuzhou TCM Orthopedics
Technical & Procurement FAQ

Frequently Asked Questions: Evaluating an OEM Testing Partner

Critical inquiries addressing analytical validation, cost mechanisms, sample shipping, IP protection, and data governance for enterprise sourcing directors.

How does MedGence deliver affordable testing without sacrificing pharmacopeial compliance?
Our price-to-performance advantage stems from three structural realities: (1) Headquartered in Changsha, Hunan, our operating overhead and scientific labor expenditures are optimized compared to North American or European facilities; (2) High-throughput automation and direct integration with our proprietary database of ~400 single-herb standards significantly cut method development trial-and-error cycles; (3) We are a direct laboratory and pilot manufacturer, eliminating external vendor markups. All assays strictly adhere to ICH Q2(R1), USP, EP, or NMPA standards with full raw analytical trace logs.
What specific analytical instrumentation is deployed for method establishment?
Our state-of-the-art instrumental suites feature high-performance liquid chromatography systems (Agilent 1260/1290 Infinity II, Waters ACQUITY UPLC) with DAD, ELSD, and FLD detectors; high-resolution mass spectrometers (UHPLC-Q-TOF-MS and Triple Quadrupole MS/MS); CAMAG automated high-performance thin-layer chromatography (HPTLC) systems with visual densitometry; and Agilent 7890B/8890 Gas Chromatography (GC-MS/FID) for volatile terpenes, residual solvents, and pesticide multiresidue quantification.
Can one single partner transition my botanical molecule from screening to commercial manufacturing?
Yes. MedGence operates as an integrated CRO/CDMO platform. Study outcomes validated in our research laboratories transfer directly to our in-house pilot plant and collaborative cGMP facilities directly supervised by our technical directors. This seamless continuity eliminates the tech-transfer pitfalls, batch failures, and months of administrative delay associated with split-vendor contracting.
How are client formulas, chromatographic elution data, and proprietary know-how safeguarded?
Confidentiality is the bedrock of our entrusted R&D model. All client engagements begin with legally binding bilateral NDAs. Analytical data, chromatographic gradients, sample identifications, and master formula dossiers are compartmentalized on encrypted, access-controlled offline servers. Laboratory technicians operate under coded project IDs without visibility into client brand identities or market applications.
How do overseas clients handle biological or botanical sample customs clearance into China?
Our regulatory logistics unit routinely manages international sample shipments from North America, Europe, Southeast Asia, and Australasia. We provide clients with pre-clearance import declarations, customs clearance permits, and guidance regarding CITES and quarantine classifications to ensure smooth customs transit of dry botanical crude, standardized extracts, and testing specimens.
What preclinical in vitro models are available for rapid screening go/no-go decisions?
We maintain an extensive bio-banking library of validated mammalian cell lines. Routine assays evaluate antioxidant capacity (ORAC, DPPH, ABTS), anti-inflammatory pathways (LPS-induced RAW264.7 macrophages measuring TNF-α, IL-6, and NO inhibition), metabolic control (glucose uptake in HepG2 and 3T3-L1 adipocytes, α-glucosidase and α-amylase inhibition), antiviral cytotoxicity, and melanogenesis suppression in B16 melanoma cells for cosmeceutical developers.
Do your clinical study capabilities satisfy criteria for human dietary claims and NDA filings?
Yes. We execute small-cohort randomized controlled trials (RCTs) for dietary supplement claim substantiation (e.g., joint mobility, metabolic response, sleep metrics) as well as full-scale Phase I–IV clinical investigations for new drug applications (NDA) in formal collaboration with accredited Class-3A university hospitals, complete with GCP-certified investigator oversight, institutional ethics review board (IRB) filings, and electronic data capture (EDC).
Contract Testing Catalog

Commission Your Custom OEM Testing Protocol

Connect directly with our senior study directors. Explore specific assay packages, review technical instrumentation benchmarks, and receive a binding feasibility proposal within 48 business hours.

OEM Testing Service OEM In Vitro Test Research Service

OEM In Vitro Test / Research Service

Cellular viability, anti-inflammatory cytokine expression, glucose uptake, and enzymatic inhibition assays providing rapid, cost-effective efficacy screening.

Fast TAT: 10-14 Days High-Throughput
Configure In Vitro Assays
ODM Origin Study ODM Study and evaluation of botanical potency

Botanical Potency & Origin Evaluation

Quantifying secondary metabolite variance across geographical origins and seasonal harvest windows to lock in the highest active yields at optimal acquisition cost.

Dao Di Botanical Geo-Mapping
Explore Origin Screening
OEM Preclinical OEM Animal study supplier

OEM Animal Study & In Vivo Toxicology

Preclinical rodents and disease-induced animal models evaluating pharmacodynamics, metabolic pathways, and targeted organ toxicity with complete histological verification.

GLP-Adherent Study Protocols
Commission Animal Study
QC Standardization China Establishment of analysis methods

Analytical Method Establishment

HPLC, HPTLC, and GC chromatographic fingerprinting method development and validation per ICH Q2(R1) to definitively verify active purity and prevent adulteration.

LOD/LOQ Validation Included
Validate Test Method
Clinical CRO ODM Clinic study Phase 1 to Phase 4

ODM Clinical Studies (Phase I – IV)

Complete human clinical research services including IRB/ethics filings, GCP protocol design, small-cohort nutraceutical trials, and Phase I–IV pharmaceutical registration data.

GCP-Compliant Execution
Design Clinical Protocol
HTS Screening China Screening of active ingredients of plants

Phytochemical Screening & Isolation

High-throughput screening across alkaloid, flavonoid, polysaccharide, and saponin fractions to identify lead pharmacophores with target receptor affinities.

10,000+ Botanical Database
Screen Active Candidates
Toxicology Suite Toxicity studies LD50 Acute and Genotoxicity

Toxicity Studies (LD50 & Genotoxicity)

End-to-end toxicological safety packages: Ames bacterial reverse mutation, chromosomal aberration, micronucleus test, and acute oral LD50 determination.

OECD Guideline Adherent
Request Toxicity Package
CDMO Scaling Natural Herbal formulation research service

Natural Formulation & Dosage R&D

Overcoming bioavailability bottlenecks, bad taste profiles, and active degradation to produce scalable capsules, softgels, granules, oral liquids, and functional tablets.

Pilot to Batch Scale-Up
Optimize Formulation
Direct Senior Scientist Engagement

Accelerate Your Analytical & Preclinical Testing Timeline

Submit your target indication, reference plant material, or analytical method parameters directly to our scientific team at [email protected]. We evaluate study feasibility and return a detailed milestone protocol within 48 business hours.